Non-genetically Modified Human Lymphocytes Added

Summary#

Order 2020-112-14-01 Amending the Domestic Substances List adds Non-genetically modified human lymphocytes to Part 5 of the Domestic Substances List. The change took effect when the order was registered on December 11, 2020.

What it does#

• Adds the living organism named Non-genetically modified human lymphocytes to Part 5 of the Domestic Substances List.
• As a result, that organism is no longer treated as a “new” substance under the federal new-substance rules, so it is no longer subject to the New Substances Notification Regulations (Organisms) for notification and assessment.
• The order was made under the Canadian Environmental Protection Act, 1999 and came into force on December 11, 2020.

Who's affected#

• People and organizations that make, import, sell or use Non-genetically modified human lymphocytes in Canada.
• That includes research labs, biotech and cell-therapy companies, hospitals and diagnostic or clinical laboratories that handle these cells.
• If it is unclear whether a specific activity is covered, the government contact listed in the order can be used to ask for guidance.

Why it matters#

• Removing the “new substance” designation means less federal pre-notification paperwork for anyone working with these lymphocytes. That can make it faster and simpler for businesses and researchers to bring these cells into use.
• The order is administrative: it does not mean the government is endorsing the substance, nor does it remove any other rules that might apply (for example, health, safety, or biosecurity rules).
• The government said the change has no expected costs or regulatory impacts and does not create new obligations for Indigenous rights or small businesses.